Ide, Iso 14971, IEC 62304, Iso 13485, PMA, IEC 60601, ISO 10993, De Novo, Regulatory Affairs, ce marking, EU MDR, Technical Files

regulatory strategy, Regulatory Affairs, Risk management, Product registration

TeamShare or other management shared content workspace, TMF Filing and oversight, Safety Database systems, Medical Terminology, PV guidelines EMEA FDA and India guidelines, Safety Submissions, Safety and Pharmacovigilance, Clinical trial process

Ms Office, Problem-Solving Skills, Interpersonal Skills, Regulatory Affairs, Communication Skills, India Medical Device Regulations 2017

Outlook, Excel, Clinical trial process, TMF Filing, Safety submissions, ICH GCP, Word, Safety Database systems, Microsoft Office Suite, Pharmacovigilance, GVP, Visio, Powerpoint, PV guidelines, Medical Terminology, Safety Reporting Plan, TeamShare

Frs, URS, GxP compliance, Validation Documentation, Pharmacovigilance Systems

sop development , Project Management, Regulatory Affairs